U.S. patent application number 13/867322 was filed with the patent office on 2013-10-24 for bag with a flexurally rigid plastic part welded into it.
The applicant listed for this patent is Fresenius Medical Care Deutschland GmbH. Invention is credited to Joern HOERMANN, Franz KUGELMANN.
Application Number | 20130281964 13/867322 |
Document ID | / |
Family ID | 49289954 |
Filed Date | 2013-10-24 |
United States Patent
Application |
20130281964 |
Kind Code |
A1 |
KUGELMANN; Franz ; et
al. |
October 24, 2013 |
BAG WITH A FLEXURALLY RIGID PLASTIC PART WELDED INTO IT
Abstract
The subject of the invention is a bag for receiving, preparing
and producing dialysis fluid. The invention relates in particular
to a bag having a sealing bordering line and a flexurally rigid
hard plastic part connected to the film material. The hard plastic
part is connected to the film material separately from the sealing
bordering line and offers an area for gripping the bag for
fastening it without having to act mechanically on the sealing
bordering line in a direct manner.
Inventors: |
KUGELMANN; Franz; (St.
Wendel/Bliesen, DE) ; HOERMANN; Joern; (Heusweiler,
DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Fresenius Medical Care Deutschland GmbH |
Bad Homburg |
|
DE |
|
|
Family ID: |
49289954 |
Appl. No.: |
13/867322 |
Filed: |
April 22, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61636771 |
Apr 23, 2012 |
|
|
|
Current U.S.
Class: |
604/410 ;
493/210 |
Current CPC
Class: |
A61J 1/16 20130101; A61M
1/1668 20140204; B65D 75/5861 20130101; A61J 1/10 20130101; A61J
1/1462 20130101; A61M 1/1656 20130101; A61M 2209/08 20130101; B65D
33/14 20130101; A61J 1/14 20130101; A61M 1/1666 20140204; A61J
2205/30 20130101; B65D 81/00 20130101; A61M 1/167 20140204; A61M
5/1414 20130101; B65D 75/5872 20130101; B65D 33/06 20130101; A61J
1/1475 20130101; B65D 75/5877 20130101; A61M 5/1417 20130101; B65D
33/1683 20130101; B65D 33/02 20130101 |
Class at
Publication: |
604/410 ;
493/210 |
International
Class: |
A61J 1/10 20060101
A61J001/10 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 23, 2012 |
DE |
102012007904.4 |
Claims
1. A bag for holding medical fluids for renal therapy consisting of
film wall sections, which are welded together peripherally along a
bordering line in at least some sections, having at least one
access port whose first end brings an inner area of the bag in
fluid connection with the outer area and which is incorporated into
the bordering line with a seal, and a flexurally rigid plastic
part, characterized in that the flexurally rigid plastic part is
connected to the film walls separately from the bordering line.
2. The bag according to claim 1, characterized in that the
flexurally rigid plastic part has receptacle areas which are
prepared for receiving the ports.
3. The bag according to claim 1, characterized in that the
flexurally rigid plastic part comprises integral fastening means,
in particular a retaining rail and/or one or more vent ports.
4. The bag according to claim 3, characterized in that the
flexurally rigid plastic part is able to form an asymmetrical
geometric shape with the integral fastening means, in particular a
U-shaped retaining rail, so that the bag can be connected to a
complementary restraint system only in one unambiguous way.
5. The bag according to claim 1, characterized in that the one
access port is welded into the bordering line.
6. The bag according to claim 1, characterized in that it is a
large volume bag with a capacity of 5 to 120 liters, preferably 30
to 90 liters, preferably 45 to 75 liters.
7. The bag according to claim 1, characterized in that it is a
multichamber bag.
8. The bag according to claim 7, characterized in that at least two
chambers of the bag are each connected to an access port, each
having one access port are connected to the outer area of the bag,
penetrating through the bordering line with a seal.
9. The bag according to claim 7, characterized in that the two
access ports are each accommodated by the flexurally rigid plastic
part.
10. The bag according to claim 1, characterized in that the
flexurally rigid plastic part is connected separately from the
sealing bordering to the film walls, in particular by welding, but
without a seal.
11. The bag according to claim 1, characterized in that the film
walls are made of an elastically extensible material.
12. The bag according to claim 1, characterized in that the
receptacles for access ports/withdrawal ports and/or vent ports
and/or tube holders are integrated into the flexurally rigid
plastic part.
13. The bag according to claim 1, characterized in that an
information carrier is fastened in the welded area of the
flexurally rigid plastic part and the film wall.
14. A method for manufacturing a bag, comprising the steps placing
at least two films one above the other or flattening a film tube,
positioning at least one access port between the films or between
opposing film sections of the flattened film tube so that the port
is in proximity to opposing sides of films or film sections,
producing a sealing bordering line by welding and/or gluing the
films or the film tube to the port, positioning a flexurally rigid
plastic part in an area between the part of the films or the film
sections of the film tube protruding beyond the sealing bordering
line, connecting the plastic part to the protruding film
sections.
15. The method according to claim 14, characterized in that the
port is attached to the material in a receiving area on the
flexurally rigid plastic material.
16. The method according to claim 14, characterized in that the
flexurally rigid plastic part is connected to the film sections by
welding or gluing or clamping.
17. The method according to claim 14, characterized in that the
connection between the films or film sections and the flexurally
rigid plastic part is not embodied to form a seal.
18. The method according to claim 14, characterized in that four
films are placed one above the other and are welded along a joint
bordering line such that at least two opposing films may be formed
from film sections of a flattened film tube to obtain a
multichamber bag with an inner bag comprising an inner chamber and
a bag surrounding the inner bag, comprising a second chamber and/or
a third chamber.
19. The method according to claim 14, characterized in that another
film piece is connected to the connecting line between the films or
film sections and the flexurally rigid plastic part.
Description
[0001] The invention relates to the field of preparing medical
solutions, in particular solutions for infusion and renal
substitution therapy. The subject matter of the invention is a bag,
in particular a multichamber bag for holding concentrates with a
circumferential seal and a holding area made of a flexurally rigid
material surrounding the feed ports and/or withdrawal ports for
fluids.
[0002] Dialysis fluids for hemodialysis or peritoneal dialysis as
well as fluids and replacement fluids for hemofiltration processes
typically contain dissolved substances, for example: [0003]
electrolytes Na, K, Mg, Ca to maintain an acceptable electrolyte
balance in the patient [0004] buffers (for example, bicarbonate,
acetate, lactate, etc.) [0005] glucose (or other osmotic agents) as
osmotic agents in peritoneal dialysis or for maintaining the blood
sugar level during hemodialysis and hemofiltration [0006] acids or
salts of acids (for example, HCl and/or Cl.sup.-, acetic acid
and/or acetate, citric acid and/or citrate) which might contribute
toward the neutralization of basic partial dialysis solutions or
are present as counterions in electrochemical equilibrium.
[0007] The substances used for dialysis solutions cannot usually be
stored in a ready-to-use mixture because these substances can cause
mutual degradation. The required stability of a component in
storage may presuppose storage conditions that would lead to
degradation of other components. One example is glucose, which can
be stored for a lengthy period of time only in a certain acidic pH
range, depending on the concentration of the glucose in solution,
without being subjected to unwanted degradation processes to an
excessive extent. At the same time, the compound sodium
bicarbonate, which is often used as a buffer in dialysis solutions,
cannot be stored under such acidic conditions because, depending on
the pH, bicarbonate tends to decompose and can release CO.sub.2.
Under decomposition conditions, the concentration of bicarbonate
changes, which is unacceptable from a therapeutic standpoint. The
rising CO.sub.2 partial pressure also makes demands of the medical
dialysis machines leading to technical problems.
[0008] A variety of alternative compositions, storage conditions
and dosage forms of dialysis solutions or concentrates are known
which permit long-term storage. It is known that the solution
components are divided into a combination of partial solutions or
concentrates so that only compatible components of a partial
solution or of a partial concentrate are stored together. For the
solutions used in peritoneal dialysis, a first partial solution
comprising glucose, which assumes the function of the osmotic
agent, is typically stored at an acidic pH together with additional
electrolytes, for example, sodium, calcium, magnesium. Another
basic or buffered partial solution is necessary to supply a
physiological mixed solution or at least a mixed ready-to-use
solution of the first part and the second part with the first
acidic partial solution for treatment. The second part often
consists of a solution or a concentrate of sodium bicarbonate and
sodium chloride. The partial solutions or concentrates are present
in several containers or in several compartments of one container.
The partial solutions or partial concentrates are present
separately, so that there is no mutual influence. Immediately prior
to use of the dialysis solution, the separate partial solutions or
partial concentrates are mixed, possibly with the addition of other
aqueous components and are prepared for the treatment.
[0009] In hemodialysis, partial solutions or partial concentrates
are often present in the dialysis machine and are mixed during the
course of the treatment to prepare a finished dialysis solution.
Partial concentrates in solid or liquid form are often used for
this purpose; these concentrates are present in individual
containers and are diluted by connection to the dialysis machine
with the help of a prepared hydraulic solution and then are
processed to yield the finished ready-to-use dialysis solution.
[0010] Other developments in dialysis have tended toward supplying
the necessary concentrates in a single container. First, this
simplifies the production and handling of the containers but
secondly this also simplifies the hydraulic system of the dialysis
machine because then only one holding unit for the partial
solutions or concentrates need be provided and fewer connections
are necessary to process the solution through the hydraulic system.
This trend can be observed in particular in acute dialysis because
a greater mobility of the treatment systems is demanded there.
[0011] In another variant, dialysis solutions for hemodialysis are
not prepared from concentrates during the course of the treatment
but instead the total required volume of the dialysis solution is
prepared in one batch in a step prior to the treatment. The batch
is stored in a tank which is prepared for connection to a dialysis
machine. In many cases, the tank is an integral component of a
dialysis treatment unit or in certain cases it may also be moved
separately from the latter. Batch dialysis may thus offer the
advantage that the treatment site can be selected relatively
independently of location through the one-time preparation of the
batch. Thus treatment stations at various locations can be used
without having to rely on a dialysis solution preparation unit or a
water connection which supplies the necessary water for diluting
the concentrates. In these cases, the dialysis solution is mixed
from concentrates on an apparatus provided for this purpose and
then is stored, usually in a portable tank.
[0012] Large-volume liquid bags, which are understood below to be
bags having a capacity of at least 5 liters, are subject to special
mechanical requirements. The film material of the bags must have an
impact strength that is high enough so that the bags will not
rupture if they fall. These requirements are demanded at low
temperatures in particular. Corresponding suitability tests have
assessed the strength of solution bags in a fall test. In this
test, bags first regulated at a temperature of 4.degree. C. are
dropped to the floor from a height of 2 meters in a room regulated
accordingly and any rupture behavior of the bags that occurs is
evaluated. In addition, the welds of the bags which are assembled
from film sections must be able to withstand certain compressive
stresses without resulting in leakage of the bag. The bag materials
must also meet additional requirements of heat sterilizability and
transparency. These requirements are relevant for solution bags in
particular which are marketed and distributed in sterilized and
ready-to-use form. The mechanical stresses to which such bags are
exposed on the distribution routes result in complaints and
unpleasant follow-up demands on the part of customers to the
manufacturers. Solution bags for peritoneal dialysis, hemodialysis
and hemofiltration are conventionally available in sizes of up to
five liters.
[0013] It is still difficult to supply large-volume solution bags
in a ready-to-use form because of the transportation logistics. For
bags which are used in batch dialysis as described above, the
solutions must be prepared at the treatment site and at the site of
use. The bags must thus be filled on-site by a suitable fluid
processing installation and can be used within the hospital ward,
and to a certain extent also regionally beyond that. Such batch
systems may require bag volumes of 30 to 120 liters. Such
large-volume bags already have a heavy load on welded sections,
e.g., the welded seams or ports welded into the bags, due to their
inherent weight.
[0014] To be able to fill or empty a bag through a port, these
ports must be incorporated into the circumferential weld which
secures the film wall sections against one another and defines an
internal volume of the bag. The ports have a through-opening
connecting the inside of the bag to the outer area so that fluid
can flow through it. The outer end of the port is connected to
additional lines or connections of the bag system of the treatment
station. It is known that the welded area of the ports should be
designed in particular for the welded connection to the film
material. Therefore so-called welding ribs have been developed,
running the transverse direction to the direction of extent of the
through-opening of the ports and running parallel with the weld of
the film. During the manufacturing process, welding tools press the
films against these relatively thin welding ribs, resulting in a
very high contact pressure locally, which seals the weld.
[0015] Beyond the simple sealing, however, these joints must also
establish a fixed mechanical connection between the film and the
port. It is customary in many cases for the bag to be supported by
means of holders at the welded ports or in a suspended position.
Depending on the volume of the respective filled bag, the film
exerts high tensile forces on the weld due to the gravitational
force of the material forming the filling. For large-volume bags,
the technical requirements for establishing the described weld in a
sealing and load-bearing manner would be too high to manufacture a
bag system with acceptable manufacturing costs in mass
production.
[0016] The tensile forces acting on the film walls due to the
gravitational force and possibly the internal hydrostatic pressure
of a filled large-volume bag on the film walls may lead to thinning
of the film material. The film wall yields to the tensile forces
because of plastic or elastic deformation. Films may be designed to
be stable accordingly despite these deformations. Reference is made
in particular to WO 2011/128185, the content of which is herewith
referenced explicitly. This document describes an elastically
extensible film which is provided for producing a large-volume
bag.
[0017] One problem that occurs in mechanical stressing of welded
sections on large-volume bags, is that the film may become detached
from its welded connection with the welding ribs of the welding
boat due to thinning. Such an effect may occur in particular
because the film material must be stretched over the curved welding
ribs of the welding boat for the welding operation. In addition,
film-stretching forces also act on this welded location due to the
force of gravity or the hydrostatic pressure of the filled bag.
[0018] It is also desirable for such plastic parts to have
functional designs such as holding sections for access ports to the
bag or a holding device to which the bag can be attached. These use
requirements also necessitate the use of a mechanically stable,
flexurally rigid material.
[0019] EP 1 554 177 discloses a method for sealing and welding
tubing ports in place between the film walls of the solution bag.
This document refers to mechanical gripping of the film, insertion
of the tube port and then welding. The problems of film elongation
are discussed, but this document does disclose a plastic part made
of a flexurally rigid material.
[0020] EP 1 438 090 discloses bag having two access ports, each of
which opens into two separate internal areas of the bag. The bag
has a holder consisting of simple receiving holes in the film
material. Such a holding device is not suitable for large-volume
bags because the film material can tear under the load of the
filled bag.
[0021] EP 1 642 614 B1 discloses a concentrate bag with a plastic
part, which is prepared functionally for adding/removing fluid and
which assumes the holder function of the bag. The plastic part is
welded to the film walls in a sealing manner via welding ribs. The
bag holds a concentrate for preparing a saturated solution, with
which a dialysis fluid can be prepared. On the whole, the bag has
only a low weight, even in the filled state, so that the problems
of ensuring the sealing function and holding function of the
welding zone of the welded hard part are not important.
[0022] U.S. Pat. No. 4,386,634 discloses a large-volume container
in which dry concentrates are placed for preparing a dialysis
solution. A liquid concentrate is prepared by adding water. The
embodiment of the connection between the film wall and the hard
part is not described in detail from the standpoint of the
fastening and sealing.
[0023] The object of the present invention is therefore to create a
bag which can withstand mechanical loads in the area of the inlet
lines and outlet lines, such that the bag at the same time ensures
a high safety for sealing storage of the material filling the
bag.
DESCRIPTION OF THE INVENTION
[0024] This object is achieved by the subject matter of Claim 1,
which is a bag for holding a medical fluid, in particular a
ready-to-use and/or spent fluid such as that which occurs in
extracorporeal blood treatment or renal therapy, and by the subject
matter of Claim 14, which is a method for producing a bag.
Advantageous embodiments are represented by the features of the
dependent claims.
[0025] This object is achieved in particular by a flexurally rigid
plastic part, which is connected to the film walls separately from
the bordering line.
[0026] This in one process for producing a bag, an inlet or outlet
port is connected with a seal to the film walls in a bordering line
of the bag to be produced. In a separate area from this sealing
welded area, a flexurally rigid plastic part is connected to the
film walls to form a mechanically load-bearing connecting zone
directed at the mechanical claims of the bag.
[0027] The bag according to the invention is constructed of film
wall sections. The walls of the bag are preferably made completely
of film materials. The film material is characterized in the sense
of the present inventive teaching in that it is a thin, flat,
flexible elastic material. Such flat plastic materials which are
present in tubular form that can be placed flatly on a surface are
also covered by this concept. Layer thicknesses of the films used
for the inventive subject matter are within the range of 50 to 500
.mu.m, in particular 80 to 300 .mu.m, depending on the design also
in the range of 100 to 250 .mu.m. The term "bag" in the sense of
the inventive teaching comprises collapsible containers which are
in a flattened form when empty due to their inherent weight. The
term bag also comprises embodiments in which parts of the bag walls
are prepared of a flexurally rigid material as long as the bag can
be folded up when empty in its overall character.
[0028] It is characteristic of an inventive embodiment that at
least two films form an inner enclosed volume along a shared
bordering line and thereby form a bag. The bordering line may be a
peripheral weld connecting two films placed one above the other.
However, the bordering line may also be understood to mean that it
consists of welds of the films only in some sections but in other
sections forms a folded film. This is the case with tubular films
in particular. Such films are placed flatly so that the two film
tube halves are placed one above the other and form a film fold at
least at the sides, this also being understood to be a bordering
line. In additional areas, the loose ends of the films must be
welded to obtain a closed bag. Access ports are created between the
films. For example, tube sections may be inserted between two films
and welded or glued in place forming a seal in the common bordering
line of the at least two films, as illustrated in EP 1 554 177.
Alternatively, the ports may also be formed from flexurally rigid
material containing the welding ribs and may be welded into the
shared bordering line of the films so as to form a seal.
[0029] The ports fulfill the function of establishing access to the
inner bag volume and the outer area. They may be connected to
additional fluid guidance means, e.g., tubes, connectors and
adaptors in order to ensure a fluid supply or fluid withdrawal.
[0030] In addition, the bag according to the invention is
characterized by at least one flexurally rigid plastic part formed
in the bag and designed to integrally accommodate the at least one
feed/withdrawal port. The term "flexurally rigid" in this context
is understood to mean that an object cannot be deformed
geometrically without destroying the functional orientation.
[0031] Flexurally rigid plastics in particular are understood to be
thermoplastic materials which are used at a temperature below their
Vicat temperature according to ISO 306. The flexurally rigid
plastic part is joined to the bag or the film walls; this is to be
understood as meaning that the plastic part is welded, bonded or
joined to the films by a clamping action. Additional fastening
methods may be considered as being equivalent if they yield a
load-bearing connection in the mechanical connection to the film
walls. It is provided in particular that the bag may be connected
to the fastening system or a restraint system by means of the
incorporated plastic part. This presupposes that the connection
between the flexurally rigid plastic part and the film wall of the
bag must be so stable that the bag can be stored in a suspended or
partially suspended manner, for example.
[0032] In particular it has been found that port accesses which
form a seal and are incorporated into the peripheral line of the
bag and a flexurally plastic part incorporated additionally for
mechanical fastening and/or restraint of the bag are advantageously
joined to the film walls of the bag by separate connecting areas.
This makes it possible to ensure that the sealing areas of the
peripheral line around the access port are exposed only to the
mechanical stress due to the hydrostatic filling pressure. However,
the sealing areas are not exposed to the mechanical stresses due to
tensile forces of the film on the sealing areas which occur, for
example, due to a suspended storage of the bag. The connection
between the flexurally rigid plastic part and the film walls then
need not be created so precisely that it fulfills a sealing
function, which is an advantage, and such an imperviousness is
preserved even with suspended storage and with the resulting
tensile forces on these joining areas.
[0033] In one embodiment the access port or additional ports, e.g.,
vent ports are incorporated into the peripheral line by
welding/gluing. Film sections protruding beyond this peripheral
line may be welded, clamped or glued to the flexurally rigid
plastic part so that the sealing area and the restraint area act on
different zones of the bag.
[0034] The flexurally rigid plastic part may comprise additional
functional units. It may be prepared to receive another access port
to direct additional fluids to the interior of the bag or to enable
venting/aerating of the bag in withdrawing or adding fluids. In
this case, each access port may be equipped with a septum, for
example, in order to be able to supply additional components of the
stored dialysis fluid by means of syringes. In addition,
hydrophobic filters may also be included by the access ports for
sterile venting and filling of the bag.
[0035] Welding methods are recommended as the preferred method for
producing joints between the bag film and the ports. Although
similar joining effects of the bag components might be achievable
through adhesive bonding, welding is preferred from a technical
production standpoint. Welding of the tubular access ports into the
peripheral line of the bag is also preferably performed by welding
methods. Welding methods are understood to also include laser beam
welding methods such as those mentioned in WO 2007/115803.
Likewise, reference can also be made to the techniques of EP 1 554
177 for welding the ports in place.
[0036] The separation of the sealing welds of the ports and the
welding of the functional flexurally rigid plastic part are
relevant in particular for bags with a large capacity. Bags having
a volume of five liters that are filled with dialysis fluid are
offered in the dialysis field in particular. When these bags are
hung at the site of treatment of the patient, the film material is
subjected to extremely high mechanical stresses due to the inherent
weight of the filled bag. The object according to the invention is
thus relevant in particular for bag sizes of more than two liters,
such as those used in peritoneal dialysis, for example. This is
also relevant for five-liter bag sizes, which are used for dialysis
fluids or replacement fluids in peritoneal dialysis, hemodialysis
or hemofiltration. There are known concepts in dialysis for
supplying bag sizes of up to 500 liters for supplying multiple
dialysis treatment stations with dialysis fluid centrally. In acute
dialysis, bag volumes of up to 120 liters may be provided, these
bags being stored in a portable tank to be connected to a dialysis
treatment station. In particular a bag with separate welding of the
sealing peripheral line and flexurally rigid plastic part is
relevant for bags in a size of 5 to 120 liters. Bag sizes with a
capacity of 30 to 90 liters, especially preferably 45 to 75 liters
are preferred.
[0037] The technical advantage of separate welding of ports in the
sealing peripheral line and accommodating the ports in the
separately welded flexurally rigid plastic part is manifested in a
bag in particular when the bag is designed as a multichamber bag.
In this case, a port may connect the internal area of a chamber
with the external area of the bag and in this way a plurality of
ports may be accommodated by the flexurally rigid plastic part
welded into the bag. Chambers may be designed differently. In one
embodiment, a chamber is formed from an inner bag and a bag
surrounding the inner bag in turn forms two additional chambers.
There is also the possibility that the inner chamber or the outer
chambers are in turn subdivided into compartments. The compartments
are divided by bordering lines which preferably consist of welds.
In another preferred embodiment, the bordering lines consist of
peel seams in at least some sections.
[0038] In this context, peelable welded connections are understood
to be joining sites of two joint partners exerting an adhesive
effect on one another due to the heat treatment. In the present
case the joining partners are two opposing film pieces of a bag
which are joined together in the welding process in welding jaws by
the action of heat and contact pressure. The welding temperature
determines the force with which the peel seam can be opened. A peel
seam is understood to be an adhesive bond which can be released
again by the application of force without resulting in a complete
tearing of the film material. In special embodiments, a peel joint
may also be understood to refer to a connection which causes
partial delamination of a multilayer film laminate when a force is
applied. In these cases, it is important that the delamination tear
does not cause complete rupture of the film material, which would
make the bag unusable.
[0039] The welded flexurally rigid plastic part is preferably
prepared so that it is able to receive multiple ports, each of
which establishes a connection to multiple chambers or compartments
of the bag. Thus this yields the advantage that a plurality of the
ports is combined on one plastic bag. This advantage is manifested
in particular when the bag is secured by means of the plastic part
in a restraint and the ports are to be connected to additional
fluid-conducting means, e.g., tubing, adapters, etc. In particular
the flexurally rigid plastic part may advantageously integrate
additional functions in all embodiments; for example, restraints
for additional objects, e.g., tubing may be provided. Furthermore,
sections of the plastic part may be separated by a parting line so
that a section of the plastic part can be broken off to show that
the bag has already been used.
[0040] For the connecting area between the film walls and the
flexurally rigid plastic part, it is not necessary for this
connection to be designed as a sealing connection. From the
standpoint of production technology it is advantageous only to be
sure that this connection, e.g., a welded, glued or clamped
connection, is designed to be so stable that it can absorb all the
mechanical forces due to the load of the filled bag. This refers in
particular to such forces which act in fastening the bag by means
of the flexurally rigid plastic part. A fastening for the bag may
appear so that the bag is supported in a freely suspended position
and is carried by means of the hard plastic part welded into the
bag. The hard plastic part is therefore equipped with eyes or a
retaining rail, which engages with complementary retaining devices.
The advantage of integrating retaining elements into the flexurally
rigid plastic part is in particular that of designing it in an
asymmetrical form. The retaining elements of the bag and the
complementary retaining device to hold the bag may thus be brought
into retaining engagement only in a certain relationship. This
ensures that improper fastening or improper connection of the bag
in the connecting parts of the dialysis treatment station is
rendered impossible.
[0041] With very large bags, a supporting apparatus is also
provided in addition to the restraint by means of the flexurally
rigid plastic part welded into the bag, and surrounds and supports
the bag in at least some sections in order to reduce the forces
acting on the connection between the film walls and the flexurally
rigid welded part.
[0042] A film material which is elastically extensible is
advantageously used by the bag in a large-volume embodiment between
5 liters and 120 liters. In filling the bag, the capacity of the
bag increases with an increase in the filling, much like inflating
a balloon. The use of such elastically extensible film materials
has the advantage for large-volume bags that a large capacity of
the filled bag can be made available using less film material. It
is thus also possible for the bag to have a volume of five liters
in the unextended state and to have a volume of 60 liters in the
filled state. A film material which may preferably be used here is
that described in WO 2011/128185, to which reference is herewith
made explicitly in all details.
[0043] The object according to the invention is especially
important in the design of bags with extensible film material. The
extension of the bag causes thinning of the films. The choice of
such film materials therefore requires higher precision in the
execution of the sealing weld. To this extent, it is especially
difficult to design a weld to be mechanically load-bearing and
sealing at the same time. Therefore, according to the invention,
welded areas which assume a sealing function are separated from
welded areas responsible for the mechanical restraint of the
bag.
[0044] In some embodiments, it is possible to use the non-sealing
welded area for additional functions besides the above-mentioned
holding of the flexurally rigid plastic part. It is provided in
particular in one embodiment that an information carrier is joined
by welding or gluing or clamping to the area forming the connection
between the flexurally rigid plastic part and the film sections.
The information carrier may be embodied as a printed film piece
which provides information about the bag and the product contained
in the bag. The information carrier may contain machine-readable
information, which can be processed optically or magnetically or
inductively by means of a reader. Examples of optical information
transmission include machine-readable barcodes or pixel codes,
e.g., dot matrix codes, as well as color codes and the like.
Magnetic transmission may be accomplished by output of information
on magnetic strips. Inductive information transmission according to
the RFID technique, which may also be associated with the bag in
one embodiment on the information carrier, this is also known. In
another embodiment, the information carrier is connected to the bag
and/or to the non-sealing area between films and flexurally rigid
plastic part by detachable means. Detachable means may include for
example, perforated film sections which allow the information
carrier to be detached. Alternatively, the film type information
carrier is connected to the bag by a peel connection. In this case
the information carrier may also be arranged separately from the
non-sealing connecting area.
[0045] The object according to the invention also comprises a
method for producing a bag, wherein sealing welded areas and
mechanically load-bearing welded areas are separated from one
another. In the method according to the invention, flat films are
placed one above the other in parallel and are joined to one
another by welding or gluing along a peripheral line. Welding
methods are preferred for use here. If the bag is constructed on
the basis of tubular films, then a flattened film tube is used to
produce the bag so that an upper film section is parallel and
opposite a lower section. To produce the peripheral line the film
tube then need not be welded or glued at the sides. In this case
the film fold formed in the flattened state forms a section of the
peripheral line.
[0046] Then the port accesses are positioned between the films to
be joined, preferably using tube ports. With the production of the
connecting peripheral line of the two films, the tube ports are
installed with a seal in the peripheral line. For example,
ultrasonic welding, mirror welding, contact welding or laser beam
welding is used to produce the sealing peripheral line with the
ports incorporated.
[0047] In another step, the flexurally rigid plastic part is
connected to film sections of the bag. To do so, a protruding film
section is used in the area where the ports are integrated into the
peripheral line. The plastic part is connected to the protruding
film sections and this may be accomplished by means of welding
techniques, gluing techniques or by clamping. The preferred joining
methods include welding methods. The plastic part may be located in
immediate proximity to the peripheral line in which the ports are
enclosed with a seal.
[0048] The flexurally rigid plastic part may be prepared for
receiving the port to be welded in situ. For example, one or more
ports may be inserted into hollow passages in the plastic part. The
connection between the port and the receptacle on the flexurally
rigid plastic part may be accomplished by gluing, heat blocking or
welding, in particular by laser beam welding. Heat blocking is a
method of bonding the materials of the tube port and flexurally
rigid plastic part under the influence of heat. In particular,
"receiving the ports on the flexurally rigid plastic part" is also
understood to mean that the port and the flexurally rigid plastic
part form an integral component. The port sections themselves may
be made of the material of the flexurally rigid plastic part.
[0049] In one embodiment, the port receiving area on the flexurally
rigid plastic part may comprise a septum to form an inlet port that
can be punctured with a needle. Another receptacle area may contain
a filter, in particular a hydrophobic filter to vent the bag in an
almost sterile manner when filling the bag or withdrawing fluid.
The filter is designed as a sterile filter which effectively
excludes the transport of microorganisms or endotoxins.
[0050] Although this describes a sequence of production steps which
describe the object according to the invention, it must be regarded
as completely equivalent to have the production steps conducted in
a different sequence. In particular it does not matter whether the
ports are first connected to the film sections of the bag and then
connected to the receptacle areas of the flexurally rigid plastic
part or vice versa. In the latter case, the tube ports are
connected in a first step to the receptacle area on the flexurally
rigid plastic by adhesive bonding, blocking or welding. In another
step, this assembled part is welded to the film material. In doing
so, the assembled part is positioned with the port ends between the
layers of film placed one above the other. Next the production step
takes place, in which the flexurally rigid plastic part is joined
to the films, or the sealing peripheral line which seals the
port(s) is produced first.
[0051] From a technical production standpoint, it is preferable if
the connecting areas between the flexurally rigid plastic material
and the films are not designed to be sealing. A sealing connection,
e.g., a welded connection requires a high manufacturing precision.
The film sections must be stretched accurately to surround hard
parts or tube ports that are to be welded into curved surfaces so
that a seal is formed. For this reason, it is sufficient if the
welded connection between the flexurally rigid plastic part and the
film is used only in those sections in which welding which is not
associated with any stretching of the material can be performed
rapidly. Therefore only planar surfaces of the film wall and the
plastic hard part and those that are aligned in parallel are
welded. The receptacle areas of the ports in the plastic part are
preferably excluded from the welding.
[0052] The method according to the invention may of course also be
used for multichamber bags, in particular also for so-called
"bag-in-bag" constructions in which an inner bag defines a first
capacity and an outer bag, i.e., a bag surrounding the inner bag,
forms a second capacity and optionally a third capacity. In this
case, it is assumed that four films layered one above the other are
used, such that the lower film may also be understood to be half of
a tubular film. This concept is also to be understood to mean that
two flattened tubular films placed one inside the other would yield
a sequence of four layers of film placed one above the other.
Likewise a flattened tubular film and two individual films would
yield a sequence of four films. In another step the ports are
positioned between the films in such a way that they are already
assigned to the chamber area of the finished bag. Thus one port can
be positioned between the first and second film or between the
second and third film or between the third and fourth film. Next,
as described previously, the sealing peripheral lines are designed
with the ports sealed in them so that in this area the four films
and the respective port are joined by the shared peripheral line.
Therefore this yields a bag having a plurality of chambers and,
depending on the respective embodiment desired, each chamber is
provided with a port access.
[0053] With the embodiment of the peripheral line or the
connection, another functional film piece can be connected between
the plastic part and the film walls. At such locations, it has
proven to be advantageous to apply an information carrier
containing information about the product in legible form or in a
machine-readable form. In particular when a bag having an
elastically stretchable film is used, regions of the bag cannot be
printed with legible information because the print image would be
destroyed when the bag is filled and the films are stretched. It
has therefore proven necessary to apply the information carrier to
the bag separately, so that the stretching of the film cannot have
any effect on it. In particular an applied film containing
information, e.g., in written form, as a barcode, as a dot matrix
code, as a magnetic strip or an RFID chip may be provided on the
front and back sides. The connection of the peripheral line or to
the connecting area between the plastic part and the film wall may
be peelable or may consist of an adhesive bond so that the
information carrier can be removed and a patient file for example,
can be inserted into a treatment record.
SUMMARY OF THE FIGURES
[0054] FIG. 1 shows a schematic view of a bag according to the
invention, in particular a multichamber bag having ports
accommodated with a seal in the peripheral line and having a
flexurally rigid plastic part incorporated separately thereof.
[0055] FIG. 2 shows another view in a lateral perspective of the
bag.
DETAILED DESCRIPTION OF THE INVENTION WITH REFERENCE TO
DRAWINGS
[0056] The bag shows, as illustrated schematically in FIG. 1, an
upper outer wall 102a and a lower outer wall 102b (not shown) which
are bordered by a joint peripheral edge 108 and are joined in a
fluid-tight manner. In a preferred version 102a and 102b are the
upper and lower films of a bag and the sealing peripheral lines 108
are formed by a joint permanent weld.
[0057] The bag has a first compartment A and an additional
compartment C2 which are filled with concentrates for preparing
dialysis fluids. The compartments A and C2 are enclosed along a
closed peripheral line by a dividing line 109a which consists of a
dividing line which is peelable in at least some sections in the
embodiment shown here. The contents of the compartments A and C1
are separated from one another by the additional dividing line
109b. The additional dividing line 109b may consist of a permanent
welded line, a partially semipermanent welded line or a peel seam.
The dividing lines 109a and 109b are preferably embodied as peel
seams and form a cohesive integral construction of peel seam
sections.
[0058] The exemplary embodiment according to FIG. 1 is also
characterized in that a connecting port 106 connects the filling
chamber 110 of the bag to the exterior of the bag via a first end
in the interior of the bag 106b and an additional end 106a outside
of the bag 101. Port 106 is preferably attached to the welded zone
120 by welded joints in a fluid-tight manner in the sealing
peripheral line 108. In addition, port 106 is accommodated by the
receptacle area 121 of the flexurally rigid plastic part 122 by
welding, gluing or blocking with a seal. Means 106 are preferably
provided at the end 106b of the port 106 to produce fluid
turbulence in the inflowing diluent. These means may be embodied as
a turbulence-generating nozzle or as a turbulence-generating frit.
In addition, port 106 consists of a tube passing through the bag in
the interior in its longitudinal extent. Thus it is ensured in the
filling process that when the bag is stored upright, for example,
by accommodating the bag on a retaining rail through the flexurally
rigid plastic part 122, the bag is filled from beneath and the
compartments A, B, C1, C2 are opened in the sequence A
simultaneously with B, before C1 and C2 due to the inner filling
pressure.
[0059] Another port 107 with a first end 107a outside of the bag
and another end 107b serves to return spent medical fluid,
preferably spent dialysis solution, to another chamber of the bag
system. Port 107 here is designed as a tube in the interior of the
bag and is provided for passing through the bag along a
longitudinal extent when the bag is stored in a hanging position,
for example, by accommodating the bag on a retaining rail of the
flexurally rigid plastic part 122. In the welding zone 111, the
tube 107 passes through the peripheral line 108a of the bag 101 and
opens into another chamber (not shown). The zone 111 may be a
fluid-tight welded location which secures the bag between the upper
and lower bordering planes 102a and 102b and is part of the welded
peripheral line 108. The chamber (not shown) is a sheathing
container, preferably a bag which is an integral component of the
container system 101. This results in a "bag-in-bag" construction
in which the bag holding the ready-to-use fluid is sheathed by a
bag holding the spent fluid.
[0060] In addition, the embodiment in FIG. 1 shows a set of
concentrate chambers B, C1 which are surrounded by another dividing
line along a closed peripheral line 109c. Another dividing line
109d separates the contents of the concentrate chambers B and C2.
In a preferred embodiment the lines 109c and 109d which are
embodied as peel seams form an integral construction of peel seam
sections developing one into the other.
[0061] In the exemplary embodiment, the compartment B contains a
glucose concentrate in powdered and/or anhydrous form or in liquid
form.
[0062] Another compartment C1 contains a concentrate, which is
incompatible with the concentrate of the compartments A and B,
i.e., has a tendency to degradation or would cause unwanted
interactions.
[0063] This embodiment also shows a peripheral line 108 which
preferably consists of a permanent weld. Additional permanent weld
lines, sections 108a and 108b, border the container contents or the
bag contents, forming an inclined bottom of the interior space.
This design facilitates the production of turbulence in the
incoming flow of diluent due to the means 106c for generating fluid
turbulence and thus facilitating the dissolving process of the
concentrates out of the compartments A, B, C2 and C1. Bordering
lines 108c and 108d impart additional stability to the field
container, in particular the bag, in the filled state. This is
important in particular for large-volume containers with which the
internal pressure can exert a tension effect on the peripheral line
108 due to the quantities contained. Large-volume bags having a
volume of 5 to 120 liters, 40 to 80 liters, in particular 60
liters.+-.15%, are to be understood as containers in this
sense.
[0064] In one embodiment, the filling chamber is filled through
port 106, dissolving the concentrates from compartments A, B, C1,
C2. To withdraw the prepared solution, the contents for dialysis
therapy or other processes are removed by means of an external
pumping means such as a rotary hose pump or a diaphragm pump. After
using the fluid thereby removed, it is returned to the bag system
through port 107 through recess 113 in the opposite films so that
the end of the port is in fluid connection with the volume of the
outer sheathing bag.
[0065] FIG. 1 also shows that the port ends 107a, 106a are
connected to additional fluid guidance means, in this case the
tubes 140, 140a. The tubes in turn have at their ends a connector
part 123 which is provided for bringing the dialysis fluid into
fluid connection with another fluid processing device such as a
dialysis machine.
[0066] Vent ports are labeled as 124 and 125; 125 may be connected
to the filling chamber 110 of the bag, for example, while port 124
is connected to the sheathing bag. When the chamber 110 of the bag
101 is filled through the port 106, excess air can escape through
the vent port 125. When spent fluid is returned through port 107
into the sheathing bag (not shown here) the necessary venting may
take place through port 124. The vent ports 124, 125 which pass
through the sealing peripheral line to the sealing locations 120c
and 120b are held by the flexurally rigid plastic part 122. The
plastic part contains receiving areas for hydrophobic membranes
124a and 125a, so that the venting of the chambers may be
accomplished under almost sterile conditions.
[0067] It is clear on the whole that four ports 106, 107, 124, 125
pass through the peripheral line 108 at the locations 120, 120a,
120b, 120c, forming a seal and are held by the flexurally rigid
plastic part 122. The flexurally rigid plastic part itself is
welded to the film 102a and to the film 102b (not shown) at the
welded spots 126, 126a, 126b, 126c. As this shows, the welded zones
are not permeable.
[0068] Through-openings in the film material of the inner bag are
labeled as 116, 117, 118, 119 and should cause the surrounding bag
to be filled uniformly when the surrounding bag (not shown) is
filled with spent fluid through port 107 and opening 113.
[0069] FIG. 2 shows another diagram of the bag according to the
invention. The outer bag is shown in this diagram. The bag system
comprising the inner bag and the outer bag is in a partially filled
condition. This diagram shows an upper film 202c which together
with the rear film 202d and the connection along the peripheral
line 208 define a closed capacity of the surrounding bag. The
accesses to the interior of the outer bag and to the interior of
the inner bag (not shown) are established through ports 206, 207,
225, 224. The ports 206, 207 are fluid ports for filling and
withdrawing fluid. The ports 225 and 224 are accesses for sterile
filling and venting during the filling and withdrawal processes.
Port 206 supplies the access to the inner bag, port 207 supplies
the access to the outer bag surrounding the inner bag. Similarly
port 225 is a vent port for the inner bag and 224 is a port for
venting the outer bag. These ports are incorporated into the
peripheral line 208 at the locations 220, 220a, 220b, 220c and are
accommodated by the flexurally rigid plastic part at the locations
221, 221a, 221b and 221c. The flexurally rigid plastic part is
connected to the film section 227 protruding beyond the peripheral
line 108 by welding for example. The port receiving areas 221,
221a, 221b, 221c are excluded from the welding.
[0070] FIG. 2 shows hose clips for receiving the hoses (not shown)
which are connected to the port ends 207a, 206a. The corresponding
tubes are labeled as 140, 140a in FIG. 1. The plastic part 222 is
preferably manufactured in an injection molding method. It is
therefore possible to integrate a plurality of functional units
into the plastic part in one working operation of injection molding
on the plastic part. In particular this also produces a plastic
part having a U-shaped cross section due to the longitudinal extent
of the plastic part. In this embodiment the plastic part is a
U-shaped retaining rail as indicated by 230. The retaining rail may
then be applied to a retaining device of a complementary shape and
then the bag is secured in a receiving unit of a dialysis treatment
station. In combination with the additional functional units of the
plastic part, e.g., ports and hose clips, an asymmetrical design of
the plastic part can be achieved with an appropriate arrangement.
Asymmetrical in this context means that a mirror image of the
plastic part cannot be formed to coincide with the original image
by rotation and displacement. As shown in FIG. 2, geometric coding
of the plastic part 222 can be established with which the bag and
the plastic part can be attached to a restraining device in a
manner not shown here only in an unambiguous manner. This is
especially important for preventing faulty operation of the
bag.
[0071] In FIG. 2 an information carrier is shown schematically and
labeled as 228. This information carrier consists of a film-type
material and is joined to the welded zone 226 on only one side via
the connecting zone 228a. The film material can be printed and can
be folded through the fastening, which is provided on only one
side. The connecting zone 228a may be detachable, for example, if
adhesive joints or blocking joints or peel seam joints are selected
for 228.
* * * * *